CompletedPhase 2/3

Oral Calcium Supplementation in Labor

United States89 participantsStarted 2024-04-30

Plain-language summary

The goal of this clinical trial is to learn if oral calcium carbonate can improve uterine contractions and labor outcomes in term pregnancies. It will also evaluate the safety of calcium carbonate when used during labor. The main questions it aims to answer are: Does oral calcium carbonate increase uterine contraction strength? Does it lead to shorter labor duration or higher vaginal delivery rates? What side effects or complications, if any, occur with calcium carbonate use during labor? Researchers will compare oral calcium carbonate to no treatment to see if it helps improve labor efficiency and reduce cesarean delivery rates. Participants will: Be randomly assigned to receive either 2,000 mg of oral calcium carbonate or no intervention Undergo monitoring with an intrauterine pressure catheter to measure contraction strength Be observed for two hours without oxytocin to assess calcium's direct effect on contractions Have data collected on labor progression, delivery outcomes, and neonatal health

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Had an intrauterine pressure catheter in place * Term gestation, greater than or equal to 37 weeks of gestation * Singleton pregnancy * Cephalic presentation * \> 18 years of age Exclusion Criteria: * incarceration * multiple gestation * active illicit drug use * abnormal clinical pelvimetry * Suspected fetal macrosomia defined as estimated fetal weight ≥4250 grams * intrauterine growth restriction * abnormal placentation * prior cesarean delivery * maternal history of arrhythmia * hyperparathyroidism * heart failure * renal or hepatic failure * nephrolithiasis * receipt of medications known to affect uterine contractility-such as magnesium sulfate, terbutaline, or recent misoprostol in the last four hours

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Contraction Frequency

Timeframe: Two hours after receiving the study medication or, for control participants, two hours after enrollment.

Uterine contraction strength

Timeframe: Two hours after receiving the study medication or, for control participants, two hours after enrollment.

Peak strength

Timeframe: Two hours after receiving the study medication or, for control participants, two hours after enrollment.

Trial details

NCT IDNCT07056062

SponsorArrowhead Regional Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

View on ClinicalTrials.gov More Uterine Contraction trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Contraction Frequency

Timeframe: Two hours after receiving the study medication or, for control participants, two hours after enrollment.

Uterine contraction strength

Timeframe: Two hours after receiving the study medication or, for control participants, two hours after enrollment.

Peak strength

Timeframe: Two hours after receiving the study medication or, for control participants, two hours after enrollment.